EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Unknown; Phase 3

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: EGFR-TKI; Drug: Chemotherapy（pemetrexed/gemcitabine）; Drug: Chemotherapy（carboplatin）

Study type: Interventional

Funder types: Other

Identifiers

NCT02859077

ShanghaiPH01

Details and patient eligibility

About

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Full description

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Signed informed consent Age >=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures

Exclusion criteria

Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

EGFR-TKI and Chemotherapy

Experimental group

Description:

NSCLC patients

Treatment:

Drug: Chemotherapy（carboplatin）

Drug: Chemotherapy（pemetrexed/gemcitabine）

Drug: EGFR-TKI